| CTRI Number |
CTRI/2021/09/036578 [Registered on: 16/09/2021] Trial Registered Prospectively |
| Last Modified On: |
15/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Whether ultrasound guided intra-articular steroid therapy efficacious in patients with lack of blood supply (avascular necrosis) of femoral head? |
|
Scientific Title of Study
|
Comparison of efficacy of ultrasound guided intra-articular steroid injection in patients with avascular necrosis of femoral head-A Prospective randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajasekaran |
| Designation |
Head of the department |
| Affiliation |
Ganga hospital |
| Address |
Department of Orthopaedics,
Ganga hospital,
313, Mettupalayam Road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994462230 |
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajasekaran |
| Designation |
Head of the department |
| Affiliation |
Ganga hospital |
| Address |
313, Mettupalayam Road, Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajasekaran |
| Designation |
Head of the department |
| Affiliation |
Ganga hospital |
| Address |
313, Mettupalayam Road, Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Orthopaedic research education foundation |
|
|
Primary Sponsor
|
| Name |
Ganga Orthopaedic research education foundation |
| Address |
313, Mettupalayam Road, Coimbatore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Soundarrajan |
Ganga hospital |
Department of orthopaedics,
313, Mettupalayam Road, Coimbatore
Coimbatore
TAMIL NADU |
9994462230
soundarortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M241||Other articular cartilage disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
patients who does not receive steroid therapy |
patients who does not receive steroid therapy |
| Intervention |
Ultrasound guided intra-articular steroid therapy |
Ultrasound guided intra-articular steroid therapy in patients with avascular necrosis of femoral head
Drug: Triamcinolone acetonide 80 mg
Duration of therapy: one time injection
Follow up: patient will be followed up for 1 year |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Age more than 20 years
• Diagnosis of avascular necrosis of femoral head (Ficat & Arlet – upto stage III)
• Pain not relieved with conservative therapy
|
|
| ExclusionCriteria |
| Details |
• Diagnosis other than AVN
• Uncontrolled diabetes
• Cushing syndrome
• Severe osteoporosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Visual Analog Score (VAS 0–10) for pain
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain/function.
• Potential predictors of response (including radiographic severity, ultrasound synovitis and baseline symptom severity) |
Pre-intervention, 1 month, 3 months, 6 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Potential predictors of response (including radiographic severity, ultrasound synovitis and baseline symptom severity) |
1m, 3m, 6m, 1y |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intra-articular steroid therapy (IAST) gives a local analgesic effect and reduces inflammation for hip osteoarthritis patients. The rationale of applying IAST is joint replacement would be their only other treatment option to relieve pain and no further damage to the joint is expected. However, no published data related to the efficacy of IAST on hip avascular necrosis (AVN) of femoral head patients. Only five RCT were published on this topic, the recent being by Atchia et al in ‘2011. A recent systemic review by Zhong et al. showed IAST had significant efficacy on hip OA in both immediate and delayed pain reduction, which persisted up to 12 weeks after IAST. The influences of the baseline severity of hip OA or synovitis and injection dose or volume on the clinical outcome of IAST are still controversial.
Our aim is (1) To study the efficacy of intraarticular steroid injection in patients with various stages of avascular necrosis of the femoral head. (2) To assess the duration of an objective improvement in pain and function. (3) To determine the predictors for a clinical and radiographic response.
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